Novo, Viatris Settle Ozempic Patent Row

 

Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.

Novo Nordisk and Viatris subsidiary Mylan on Monday reached a settlement in their patent dispute over the blockbuster incretin therapy semaglutide.

According to a filing by Indian company Natco Pharma, the terms of the settlement are confidential, so the companies’ financial arrangements are unknown. It is also unclear when generic versions of semaglutide are allowed to enter the U.S. market. Natco is partnered with Mylan on the development of these generics.

In accordance with the settlement, Novo and Viatris on Monday also submitted a joint filing to the U.S. Patent and Trademark Office (PTO) asking it to terminate all proceedings and pending motions related to the patent dispute.

Novo sued Mylan in 2022 claiming patent infringement. According to the lawsuit, filed in the District Court for the Northern District of West Virginia, Mylan had filed an abbreviated New Drug Application (ANDA) for a generic version of Ozempic, the brand of semaglutide indicated for type 2 diabetes.

Novo argues that in filing its ANDA, Mylan signified its intention to “sell, offer to sell, use, and/or engage in the commercial manufacture” of an Ozempic generic that would violate nearly 20 of its patents that have yet to expire. In particular, Mylan’s generic uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics.

The pharma at the time asked the court to prevent Mylan from manufacturing and selling its generic version, pending approval, before the expiration of any of the patents under contention, including extensions.

Novo has since filed other lawsuits against Mylan, including one in July 2024 that focused on two patents—concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes—that Mylan’s ANDA allegedly violated.

Mylan, meanwhile, has challenged the validity of Novo’s patents. According to Monday’s joint document to the U.S. PTO, Mylan filed for an inter partes review in March 2023. The PTO Board started its review a few months later, in October 2023.

Ozempic works by mimicking the GLP-1 hormone and activating its corresponding receptor. Through this mechanism of action, Ozempic promotes the secretion of insulin from the pancreas in response to a rise in blood sugar levels. The drug also slows gastric emptying and helps suppress appetite. Ozempic’s sister brand Wegovy is indicated for chronic weight management.

Ozempic made around $14 billion in 2023, while Wegovy earned another $4.5 billion.

https://www.biospace.com/policy/novo-viatris-settle-ozempic-patent-row

Setback for J&J's TAR-200 bladder cancer program

 A phase 3 trial of Johnson & Johnson's TAR-200 therapy in bladder cancer has failed to show efficacy, although the company is still confident in the potential of the programme.

The SunRISe-2 study, in people with muscle-invasive bladder cancer (MIBC) who were not receiving surgery to remove the bladder (cystectomy) and nearby lymph nodes, has been discontinued after it showed no improvement over the standard chemoradiation treatment for this patient population.

J&J acquired rights to the silicone-based drug delivery service used in TAR-200, which allows for the continuous release of medication to the bladder, when it bought privately-owned biotech Taris for an undisclosed sum in 2019. In the case of TAR-200, it it is being used to deliver the chemotherapy agent gemcitabine.

In a statement, J&J said that the trial – which looked at the combination of TAR-200 with J&J's experimental PD-1 inhibitor cetrelimab given systemically – was "a bold approach to disrupt the established standard of care" and the disappointing result has had no bearing on its projections of a $5 billion-plus peak sales potential for the Taris platform overall.

"We are highly confident in TAR-200 as a transformative therapy for bladder cancer, where innovative and bladder-sparing options are urgently needed," it added, pointing to recently-presented data at the 2024 ESMO cancer congress from the SunRISe-4 trial in MIBC.

SunRISe-4 looked at the combination of TAR-200 with cetrelimab as neoadjuvant (pre-surgery) treatment for non-metastatic MIBC patients who were ineligible for or refused neoadjuvant platinum-based chemotherapy and were scheduled for a cystectomy.

It revealed a pathologic complete response (pCR) rate of 42% with the duo versus 23% with cetrelimab alone, and a pathological overall response (pOR) rate of 60% and 36%, respectively.

Meanwhile, at last year's ESMO, J&J reported positive results from the phase 2 SunRISe-1 study of TAR-200 in non–muscle-invasive bladder cancer (NMIBC) unresponsive to first-line therapy with BCG, achieving a 77% overall response rate.

J&J reiterated its plan to file for approval of TAR-200 as a monotherapy for NMIBC – which is more common than MIBC and accounts for around three-quarters of all cases of bladder cancer – early next year.

Meanwhile, the company is also running another study (SunRISe-3) that it hopes will allow it to position TAR-200 as a replacement for BCG. SunRISe-3 is testing the drug with and without cetrelimab in BCG-naive NMIBC patients and should see data emerge in the next 12 months.

Also on the go is SunRISe-5, a phase 3 trial of TAR-200 as a second-line therapy for high-risk NMIBC patients who have previously received BCG treatment and are unwilling or unable to have a cystectomy.

Following after in J&J's Taris-derived pipeline is TAR-210, an intravesical formulation of J&J's FGFR kinase inhibitor Balversa (erdafitinib), which started the phase 3 MoonRISe-1 trial in intermediate-risk NMIBC earlier this year.

https://pharmaphorum.com/news/setback-jjs-tar-200-bladder-cancer-programme

Home security firm ADT Inc reports unauthorized activity on its network

 Home security firm ADT Inc said on Monday an unauthorized actor had illegally accessed its network using credentials obtained through a third-party business partner.

Shares of the company fell 1.8% after the bell.

Monday's incident comes just months after the company reported a separate cybersecurity breach where the unauthorized actors accessed ADT's customer order details and "limited" customer information, including email addresses, phone numbers and postal addresses.

The company has taken steps to shut down the unauthorized access and launched an investigation into the incident, which it said is at an early stage and still ongoing.

ADT said, in a regulatory filing, that the unauthorized actor took certain encrypted internal data associated with employee user accounts. However, it does not believe any customers' personal information or their security systems were compromised, the company added.

ADT said it is working closely with federal law enforcement and external cybersecurity experts to help with its response to the incident.

The company has also implemented countermeasures to help safeguard its information technology assets and operations, which have resulted in some disruptions to ADT's information systems, the company said in the filing.

https://finance.yahoo.com/news/home-security-firm-adt-inc-222208599.html

US House panel probes FCC decision to deny Starlink nearly $900 million

 A U.S. House committee said on Monday it is investigating the Federal Communications Commission's decision to deny SpaceX satellite internet unit Starlink $885.5 million in rural broadband subsidies.

The FCC said in December reaffirming its position that the decision impacting Elon Musk's space company was based on Starlink's failure to meet basic program requirements and that Starlink could not demonstrate it could deliver promised service after SpaceX had challenged the 2022 decision.House Oversight Committee Chair James Comer, a Republican, asked the FCC in a letter Monday to turn over documents by Oct. 21 on the decision. The committee seeks to ensure the FCC "followed established processes and is not improperly using the regulatory process for political purposes."

The FCC said it had received the letter and would respond.

In December 2020, the FCC tentatively awarded $9.2 billion to over 300 bidders to deploy high-speed broadband with SpaceX's Starlink winning $885.5 million in a 2020 auction for rural service.

The FCC opted to deny Starlink the funding in August 2022, citing speed-test data after Starlink had agreed to provide high-speed Internet service to 642,000 rural homes and businesses in 35 states.

Musk has harshly criticized the FCC decision to deny the award he called "illegal" and asserted last week that if Starlink had received he funding "it would probably have saved lives in North Carolina" amid Hurricane Helene.

FCC Chair Jessica Rosenworcel told Congress in February that Starlink's publicly available performance data has confirmed its prior finding that "Starlink had difficulty meeting the basic uplink and downlink speed standards for the program" and added Starlink’s proposal would have required subscribers to purchase a $600 dish to start service.

The two Republican commissioners on the five-member FCC dissented from the decision saying the FCC was improperly holding SpaceX to 2025 targets early.

Last month, Rosenworcel said she wants to see more competition to Starlink, noting it controls nearly two-thirds of all active satellites and has launched about 7,000 satellites since 2018.

"Our economy doesn't benefit from monopolies. So we've got to invite many more space actors in, many more companies that can develop constellations and innovations in space," she said.

https://finance.yahoo.com/news/us-house-panel-probes-fcc-184123221.html

Akoya Platform Picked by UK Consortium to Revolutionize Cancer Immunotherapy

 Consortium includes top universities, hospitals and industry partners, led by the Francis Crick Institute and The Royal Marsden NHS Foundation Trust

Akoya’s platforms will be used for deep spatial proteomic profiling of thousands of tissue samples from cancer patients to identify biomarkers predicting treatment success

https://www.globenewswire.com/news-release/2024/10/07/2958859/0/en/Akoya-s-Leading-Spatial-Proteomics-Platforms-Selected-for-Use-by-Ground-Breaking-UK-Based-MANIFEST-Consortium-to-Revolutionize-Cancer-Immunotherapy.html

Georgia Supreme Court Reinstates State's Abortion Law

 by Zachary Stieber via The Epoch Times (emphasis ours),

A judge’s ruling striking down Georgia’s abortion ban was stayed on Oct. 7 by the Georgia Supreme Court.

The stay means the ban on abortions after a fetal heartbeat is detected will go back into effect as the case proceeds.

Six justices granted a request by Georgia officials to reinstate the law after a county judge on Sept. 30 concluded that the law violates the right of women in the state to have an abortion.

Georgia’s Constitution gives residents liberty, and that liberty includes the right of women to “control what happens to and within her body,” Fulton County Superior Court Judge Robert McBurney said in his ruling.

In a one-page order from the Georgia Supreme Court, a majority of justices said they were staying McBurney’s ruling as of 5 p.m. on Oct. 7. The majority did not explain their reasoning.

The law states that abortion is not authorized if the heartbeat of an unborn child has been detected. Exceptions include cases where doctors determine a medical emergency exists and, in some instances, incest or rape.

The Georgia Supreme Court order does not impact the block of a provision that would provide abortion-related health records to district attorneys.

According to the high court, Justice Nels S.D. Peterson was disqualified from considering the state’s emergency request to intervene, and Justice Andrew A. Pinson did not participate.

In an opinion concurring in part and dissenting in part, Justice John J. Ellington said the state had not provided sufficient arguments to prompt a stay, particularly in light of how groups suing over the law met the burden of establishing that the law violates Georgia’s Constitution.

“Fundamentally, the state should not be in the business of enforcing laws that have been determined to violate fundamental rights guaranteed to millions of individuals under the Georgia Constitution,” he wrote. “The ’status quo' that should be maintained is the state of the law before the challenged laws took effect. Accordingly, I dissent.”

Ellington concurred only with the choice not to reinstate the provision concerning health records.

Justices Michael P. Boggs, Sarah Hawkins Warren, Charles J. Bethel, Carla Wong McMillian, Shawn Lagrua, and Verda M. Colvin formed the majority.

The stay is in place as the state lodges an appeal, which will be heard in due course. The stay could become permanent or ultimately be withdrawn.

The abortion bill was approved by the Georgia Legislature in 2019 and the law took effect in 2020.

https://www.zerohedge.com/political/georgia-supreme-court-reinstates-states-abortion-law

Iran Earthquake Sparks Speculation, Rumors Of Covert Nuclear Weapons Test

 Via The Cradle

On Saturday a 4.5-magnitude seismic event occurred in Iran’s Semnan province, sparking speculation that Iran has tested a nuclear weapon for the first time. Such a seismic event is typically the result of an earthquake, but speculation has arisen on social media suggesting the event was instead an underground nuclear test carried out by the Islamic Republic in response to Israeli threats to bomb Tehran’s nuclear energy and oil facilities.  

According to Iranian sources speaking with The Cradle, the possibility that a nuclear test was indeed conducted is being discussed at high levels in Iran. Syrian sources speaking with The Cradle in September predicted that Iran would seek to develop breakout nuclear weapons capability in response to Israel’s assassination of Hamas leader Ismail Haniyeh in Tehran.

Iran launched at least 180 ballistic missiles at Israel, causing damage to three airbases on October 1, following Israel’s assassination of Hezbollah leader Hassan Nasrallah and IRGC commander Abbas Nilforushan on September 27. Iran is now awaiting a possible Israeli response.

The speculation that Iran carried out a nuclear test comes just days after the Heritage Foundation, a right-wing think tank in the US, published a report stating that "Iran can produce nuclear weapons far more rapidly than expected."

Published on October 1st, the report noted that in late April 2024, a senior Iranian lawmaker stated that there is only a "one-week gap from the issuance of the order to the first test" of a nuclear bomb.

In May, an adviser to Iranian Supreme Leader Ayatollah Ali Khamenei warned that Iran may be forced to change its nuclear doctrine, which until now has called only for using nuclear technology for civilian purposes. "We have no decision to build a nuclear bomb, but should Iran’s existence be threatened, there will be no choice but to change our military doctrine," Kamal Kharrazi stated.

The Heritage Foundation report added that in July, US Secretary of State Antony Blinken seemed to corroborate this claim when he stated that "instead of being at least a year away from having the breakout capacity of producing fissile material for a nuclear weapon, [Iran] is now probably one or two weeks away."

The statements accompanied a significant increase in Iran’s stockpile of Uranium enriched to the 60 percent level between May and August 2024, according to a report by the International Atomic Energy Agency (IAEA).

Notably, Uranium that is enriched up to 60 percent purity is just a short, technical step away from the 90 percent required for nuclear weapons, the report added.

The Foundation for Defense of Democracy (FDD), an Israeli-linked think tank based in Washington, DC, issued a report in 2019 claiming that Iran had begun a program to build underground nuclear test sites starting in the 2000s known as "Project Midan."

The FDD stated, "Using openly available, corroborating geospatial information, we have identified the likely location (in an area southeast of Semnan) where underground non-nuclear explosives tests were conducted in 2003 as part of developing seismic methods of measuring the yield of an underground nuclear explosive."

https://www.zerohedge.com/geopolitical/iran-earthquake-sparks-speculation-rumors-covert-nuclear-weapons-test